Fluid Restriction in Respiratory Distress of the Newborn

NCT ID: NCT03120585

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-03-31

Brief Summary

The object of this study is to determine the best way to care for infants with respiratory distress. The investigators are testing a method of feeding fluids to infants with respiratory distress in amounts similar to what healthy breastfed babies eat when they are feeding on demand, and comparing this method to the current standard of care for feeding fluids to infants with respiratory distress. These methods of feeding fluids to the study infants will continue until the infants are able to feed normally by mouth. The study will include about 400 infants across five sites in the United States, Chile and Argentina.

Detailed Description

Infants with respiratory distress syndrome will be enrolled within the first twelve hours of life, and randomly assigned to one of two groups: the first group will receive the interventional fluid management method, and the second (the control group) will receive the current standard of care for fluid management. To standardize respiratory care across all five study sites, a computer-based algorithm for respiratory support management based on objective markers of respiratory distress will guide clinician management decisions. However, each infant's medical team will make all final decisions on respiratory treatment and IV fluid management. Any study infant who experiences dehydration and/or low blood sugar during the course of the study will be removed from the study and be treated for the condition.

Conditions

Respiratory Distress Syndrome, Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluid Management Intervention

Restricting IV fluids to infants with respiratory distress to mimic fluid intake of normal healthy breast fed infants (less fluid that current standard of care)

Group Type: EXPERIMENTAL

Fluid Management Intervention

Intervention Type: OTHER

Fluid management intervention is fluid restriction to 60 mL/kg/day on Day of Life (DOL) 1 for preterm and 40 mL/kg/day on DOL 1 for term neonates, calculated as total of IV and enteral fluid intake. Infants randomized to low infusion with be placed on 10% dextrose and the Infant will be monitored by obtaining serum glucose levels by point of care testing. Glucose infusion rates (GIR) would be calculated to the corresponding serum glucose and recorded. After 24 hours, infusion rate will be increased to 60ml/kg/d providing minimum GIR \>4mg/kg/d. . Total fluid intake will be increased by 20 mL/kg/day until 150 mL/kg/day .

Control Group

Infants with respiratory distress will receive standard of care fluid management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fluid Management Intervention

Fluid management intervention is fluid restriction to 60 mL/kg/day on Day of Life (DOL) 1 for preterm and 40 mL/kg/day on DOL 1 for term neonates, calculated as total of IV and enteral fluid intake. Infants randomized to low infusion with be placed on 10% dextrose and the Infant will be monitored by obtaining serum glucose levels by point of care testing. Glucose infusion rates (GIR) would be calculated to the corresponding serum glucose and recorded. After 24 hours, infusion rate will be increased to 60ml/kg/d providing minimum GIR \>4mg/kg/d. . Total fluid intake will be increased by 20 mL/kg/day until 150 mL/kg/day .

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Neonates born between 34-0/7 and 41-6/7 weeks gestational age (GA) at birth with primary pulmonary disease of the newborn including Transient Tachypnea of the Newborn (TTN), Respiratory Distress Syndrome (RDS), air leak syndrome, pneumonia, or meconium aspiration syndrome in the first 12 hours of life will be eligible for inclusion in this study.
• Those neonates who are intubated for administration of exogenous surfactant but who are immediately extubated to non-invasive respiratory support after surfactant administration will remain eligible for study inclusion.

Exclusion Criteria

• Neonates with a genetic abnormality or congenital anatomic anomaly

Subsequent Study Exclusion resulting in removal from study:

• Neonates who subsequently undergo endotracheal intubation and mechanical ventilation for refractory respiratory distress
• Neonates with hypoglycemia or clinical evidence of dehydration or volume depletion requiring fluid bolus
• Infants that are transported out of the participating site prior to study endpoint.

• Maximum Eligible Age: 12 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Universidad Abierta Interamericana

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abhishek Makkar, MD

Role: STUDY_DIRECTOR

University of Oklahoma HSC

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Comanche county Memorial hospital

Lawton, Oklahoma, United States

Countries

United States

References

Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2014;2014(12):CD000503. doi: 10.1002/14651858.CD000503.pub3. Epub 2014 Dec 4.

Reference Type: BACKGROUND

PMID: 25473815 (View on PubMed)

Stroustrup A, Trasande L, Holzman IR. Randomized controlled trial of restrictive fluid management in transient tachypnea of the newborn. J Pediatr. 2012 Jan;160(1):38-43.e1. doi: 10.1016/j.jpeds.2011.06.027. Epub 2011 Aug 11.

Reference Type: BACKGROUND

PMID: 21839467 (View on PubMed)

Other Identifiers

4688

Identifier Type: -

Identifier Source: org_study_id